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Completed

NCT Number: NCT03853512

A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.

After the peeling, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

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Key information

Conditions

Skin Recovery Behavior Consumer Behavior

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medcin Instituto da Pele

São Paulo, 06023-070, Brazil

About this study

The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Phototypes I and II according to the Fitzpatrick scale;
  • Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.

Exclusion criteria

  • Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
  • Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
  • Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area

Treatment and study plan

BAY207543 (Bepanthol, Bepantol® Derma Spray)

Drug

Product is applied to one side of the inguinal region.

Semisolid vaseline

Other

Product is applied to the other side of the inguinal region.

Primary outcomes

  1. Transepidermal water loss by TEWL probe

    Time frame: Up to 23 days

    The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.

Secondary outcomes

  1. Skin properties of the participants

    Time frame: Up to 23 days

    Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 12 to 60 (a higher score represents higher efficacy).

  2. Treatment satisfaction

    Time frame: Up to 23 days

    Participants assess their treatment satisfaction with a questionnaire consisting of 19 items (each item is scored from 1-5) resulting in a score range of 19 to 95 (a higher score represents better treatment satisfaction).

  3. Product evaluation

    Time frame: Up to 23 days

    Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 6 items (each item is scored from 1-5) resulting in a score range from 6 to 30 (a higher score represents higher product satisfaction).

  4. Number of adverse events by dermatological evaluation

    Time frame: Up to 23 days

  5. Number of adverse events by gynecological evaluation

    Time frame: Up to 23 days

  6. Severity of adverse events by dermatological evaluation

    Time frame: Up to 23 days

  7. Severity of adverse events by gynecological evaluation

    Time frame: Up to 23 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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